From Dismay to Hope: Advanced Prostate Cancer, PROVENGE and Prolonging Life.

Christmas for me has always been a joyous occasion but this past December, 2016 it included an element I had always dreaded. My prostate cancer had been kept under control with a combination of intermittent and continuous Lupron® injections for ten (10) years. Every time I had received positive results from my PSA tests, I felt as if God had given me a 4-month reprieve of life.  I could forget my cancer for a while and live my life happily and productively until the next test. I knew I wouldn’t be cured but I had hoped above all hopes that the hormone therapy would work long enough for me to die of another, less-painful scenario. In December 2016, I found that the hormone treatments had stopped working and I was now classified with refractory, advanced prostate cancer though thankfully asymptomatic. My Florida urologist had always hoped that this “bad day” would never come but now he told me I could expect 2-3 “good years” of alternative treatments until metastatic disease would overtake me. He shook my hand and referred me to the care of my Florida oncologist. Upon seeing my oncologist, his first words to me were “what do you want to do now?” Though I am a Ph.D. scientist, I am neither an M.D. nor a trained oncologist so I looked at him with a sense of bewilderment and confusion. I later learned that this approach was something called “patient-centered care” wherein I was to be totally involved in my therapy. Information shared below indicates that my first choice of therapy, PROVENGE® (sipuleucel-T), way be the right one.

Well, in writing this website I knew something about the few therapeutic agents available to me at this stage, so my oncologist and I listed them including enzalutamide (Xtandi®), taxotere (docetaxel®), abiraterone (Zytiga®) and PROVENGE® (sipuleucel-T). In looking over my website listing of drugs currently under development for advanced prostate cancer, I was dismayed to note the significiant number of late clinical stage failures [e.g. custirsen (OGX-011),  galeterone (TOK-011), orteronel (TAK-700), ipilimumab (Yervoy)] which reinforced the fact that my options were getting fewer and the prospect of dying of prostate cancer was becoming more of a reality. Since I am asymptomatic at this point, another possibility was to do nothing until symptoms or metastases appeared on various scans. I remembered that I had written a blog dated October 28th, 2014 wherein four prostate cancer experts had recommended the early use of PROVENGE® in treating refractory, asymptomatic disease. Fortunately, PROVENGE® was available for me at my specific treatment site and in April, 2017 I started my treatment which I will describe below.

PROVENGE was studied in Phase 3 clinical trials involving 512 men with metastatic, hormone-resistant prostate cancer in the IMPACT trial. It was found that PROVENGE had a more pronounced treatment effect in men with lower, decreasing baseline PSA. Thus, men with lower cancer burden may benefit most from PROVENGE therapy administered at an early stage of advanced cancer. These men may tend to experience less immunosuppression systemically and in the tumor microenvironment. Immuno-treatment such as PROVENGE also has a delayed onset of action and is capable of generating a sustained response. Therefore treatment earlier in the disease would allow more time for the patient to benefit from the therapy. This data seemed to fit my current status. My oncologist refers to me as “the best of the worst”.

As published in the June 2013 issue of Urology [Schellhamer et al; 81(6),1297-1302] the median overall survival in men whose baseline PSA was lower than 22 ng/mL was 41.3 months as opposed to 28.3 months in the control, untreated group for an overall median survival benefit of 13 months. Estimated 3-year survival for the lowest PSA group receiving PROVENGE was 62.6% for PROVENGE patients versus 41.6% for the control group.

Was God leading me in this choice? Clinical trial data for PROVENGE seems to indicate it is an excellent choice for me at this point. I have a sense of peace especially as God has paved the way for me in the administration of this therapy even to the point of giving me good, useful veins as would be needed (see below). Is it possible that God could extend one’s life even though His Word states that He has our days “numbered?” One day, my daily devotionals included a section from the Old Testament book of Deuteronomy, often not known for its inspirational themes but a more historical book. In this reading, Deuteronomy 6:2 seemed to leap out at me. It states that I should “fear (respect) the Lord your (my) God, to keep all His statutes and commandments…….all the days of your (my) life, and that your (my) days may be prolonged.” Did God intend to speak to me through this verse? Could He prolong my days? I cannot say for certain. But even though I don’t know how many years I have left, I daily “present my body a living and holy sacrifice acceptable to God which is my spiritual service of worship” according to Romans 12:1. I will trust in God’s wisdom and that of my physicians. I’ll keep writing this website. As I believe Jesus once told me (see video link), I’ll keep doing what He told me to do and He’ll care for my body.

How Provenge works: PROVENGE is a cellular immunotherapy designed to induce an immune response targeted against prostatic acid phosphatase (PAP), an enzyme (antigen) produced (expressed) by prostate cells and found in higher amounts in most prostate cancers. PROVENGE consists of a patient’s own white blood cells [T-cells, B-cells, natural killer (NK) and other cells] including antigen-presenting cells (APC), specialized white blood cells that help fight off foreign substances that enter the body. These APC cells send out signals to T-cells (other immune system cells) when an antigen enters the body. In PROVENGE, a person’s APC’s have been activated with a synthetic combination (recombinant) of two human proteins, PAP and granulocyte-macrophage colony stimulating factor (GM-CSF) an immune cell activator. These activated immune cells may be able to recognize and attack certain prostate cancer cells. During the process of generating PROVENGE from a person’s white cells, the resulting mixture remains active outside the body for only a matter of days. Therefore it is imperative that the patient and physicians adhere to a personalized leukapheresis and infusion schedule usually three days apart.

Approximately three days before receiving Provenge®, white blood cells (T-cells, B-cells, etc) are collected by passing whole blood extracted through a small tube (catheter, a large bore needle) placed in a vein in the right arm through a machine which extracts the white cells and the unextracted blood is returned through a smaller needle placed in a vein in the left arm. This process called leukapheresis usually takes about three hours. If the arm veins are insufficient for the blood collection, then a venous catheter will be placed into a vein in the next or upper chest. I was told at the blood bank that a catheter is necessitated in the majority of cases but even though some medical personnel have difficulty drawing my blood, my arm veins were of sufficient quality to be used (a real praise). The collected cells are then sent to a laboratory where PROVENGE is generated.  The prepared sipuleucel-T (PROVENGE) solution (which has an expiration time) is then shipped to a local infusion center, where it is injected back within three (3) days after collection. The infusion takes about an hour. The entire collection, cell transformation and re-injection process is very time-dependent and requires strict coordination between blood-drawing centers, laboratory and infusion sites. While there are some side effects possible, I only experienced mild fatigue after the collection and infusion processes. The process is somewhat cumbersome yet very do-able and worthwhile if prescribed for your early stage advanced cancer.